Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-Compulsive Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

July 24, 2008

Last Updated Date

July 25, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The difference of Y-BOCS score average from baseline to 16-week [ Time Frame: baseline and16-week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00723060 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A [ Time Frame: every 2 week ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-Compulsive Disorder

Official Title ^ICMJE

Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-Compulsive Disorder (Randomized, Double-Blind, Multi-Center Study)

Brief Summary

OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD).

OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S & -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

Drug: escitalopram

Study Arms / Comparison Groups

Active Comparator: escitalopram high dose group
Active Comparator: escitalopram conventional group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

166

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Man or woman, aged 18 to 65 years, outpatient
Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months
Severity: Y-BOCS score of >= 20 at screening and baseline
No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening
Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.

Exclusion Criteria:

primary active DSM-IV axis I diagnosis other than OCD
History of substance, including alcohol, dependence and psychotic symptoms
Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of >17 at screening or baseline
Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity
History of no response to escitalopram or citalopram treatment
History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening
Women who are pregnant, planning to become pregnant, or breast-feeding
Ongoing cognitive behavior therapy (CBT) of OCD
Hoarding or collecting type
Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jun Soo Kwon, M.D., Ph.D.

kwonjs@snu.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00723060

Responsible Party

Seoul National University Hospital, Seoul National University Hospital

Study ID Numbers ^ICMJE

11769A

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jun Soo Kwon, M.D., Ph.D.

Seoul National University Hospital, Seoul, Korea

Information Provided By

Seoul National University Hospital

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP